Scoliosis children’s MAGEC spinal rod treatment is halted
Clinicians are being advised not to implant MAGEC spinal rod systems used to treat children with scoliosis after the UK healthcare regulator identified several shortcomings with technical documentation and quality management.
Posted on 13 May 2021
The advice was included with other guidance released by The Medicines and Healthcare products Regulatory Authority (MHRA) in Device Safety Information on 10 May 2021.
The MHRA has recommended that where removal will not cause additional harm, the device should be removed as soon as possible.
Hospitals are expected to be required to contact affected patients, mainly children, and recall them to spinal units for close monitoring through repeated x-ray imaging.
The MAGEC system, manufactured by US company NuVasive Specialized Orthopaedics Inc (NSO), was intended to reduce the need for repeated spinal surgeries in children with scoliosis, a congenital condition that can lead to severe spinal curvature and related developmental issues.
Traditionally, paediatric scoliosis has been treated with the implantation of metal rods along the spine which can be both painful and traumatic as new spinal rods have to be implanted as children grow. As the MAGEC system was intended to reduce the need for the surgeries and the attendant risks by creating a magnetic spinal rod that could be manipulated on the surface of the skin without invasive surgery, it was marketed as a safer and cheaper alternative to a traditional system.
However, NSO sent a targeted communication to clinicians on 6 May 2021 advising them not to implant the MAGEC device and the Targeted communication confirms that the CE mark has been suspended for all MAGEC systems. Although the CE mark is a European safety mark, the UK will continue to recognise the CE mark for medical devices until 30 June 2023.
The MHRA Medical Device Alert (MDA) of 1 April 2020 regarding the MAGEC system is the latest of repeated alerts by the MHRA about the system dating back to 2014 onwards.
The 1 April 2021 MDA provides that surgeons:
- Do not implant MAGEC rods in the UK until further notice
- Identify all patients implanted with a MAGEC System and ensure systems are in place to follow up these patients
The MHRA updated its recommendations to clinicians regarding the system after consulting with its Spinal Expert Advisory Group.
Now it is anticipated that hospitals across the UK will be required to contact patients implanted with this device and recall them to spinal units so that their devices can be monitored more closely, through repeated x-ray imaging.
The MHRA has also recommended that where removal will not cause additional harm, the device should be removed as soon as possible (under priority 3 of the clinical guide to surgical prioritisation which requires surgery to be undertaken within three months).
The problems with the MAGEC spinal devices were part of Panorama’s Great Implant Scandal documentary which aired in 2018. The documentary highlighted concerns about several implanted medical devices. Concerns about the MAGEC system were also reported by the International Consortium of Investigative Journalists (the ICIJ) in their seminal study, ‘Implant Files’, a global investigation which reported on concerns about medical devices which have been tested inadequately or not at all.
Zahra Nanji, a product liability lawyer at Leigh Day commented:
“From allegedly defective breast implants, metal on metal hips and other devices designed to be implanted into the human body, history has taught us that such devices should be subject to the highest levels of safety testing prior to release on the market in then rigorous post marketing surveillance. This testing and monitoring should be even more rigorous where the device is specifically for implantation in children and where it has the possibility of a lifetime of adverse impact, should the device be defective.”